Washington (AP) — Following attacks from parents and politicians, President Joe Biden’s administration eased a national shortage of infant formula on Monday, including the reopening of the country’s largest manufacturing plant and increased imports from abroad. Announced measures to do so.
The Food and Drug Administration said it is streamlining its review process to make it easier for foreign manufacturers to start shipping more prescriptions to the United States.
“The FDA expects that measures and measures with infant formula makers and others will mean that supplies are in progress or on the shelves,” FDA Commissioner Robert Caliph told reporters.
Caliph said the United States prioritized companies that could provide the largest cargo and quickly documented that their formulations were safe and compliant with US nutritional standards. This policy is structured as a temporary measure that lasts for 6 months.
The import announcement came shortly after regulators announced that they had reached a contract allowing Abbott Nutrition to reopen a plant based in Sturgis, Michigan, which had been closed since February due to pollution problems. I did. The company must overhaul safety protocols and procedures before resuming production.
Neither procedure has an immediate impact due to tight supply, and many parents are looking for infant formula online or in food banks.
Abbott said it would take eight to ten weeks for new products to begin arriving in stores after the FDA’s approval. The company had not set a schedule for resuming production.
Imports into the US supply chain will also take weeks, according to government officials. Australian, New Zealand and UK products are expected to meet the standards required for imports.
However, according to regulatory agencies, on average, 80% of formula inventory is still in stock at most stores in the United States, according to domestic industry data. They suggested that some of the empty shelves seen recently could be due to panic buying by parents.
The announcement on Monday was previewed last week by the White House, which has relied on the FDA and formula makers to quickly find ways to mitigate the shortage. Anger over this issue quickly snowballed, handing the Republicans a new issue for use against President Biden prior to the November elections.
The shortage is due to a February recall by Abbott, which exacerbated the ongoing supply chain disruption among formula makers and reduced the shelves of many stores across the country. Due to the shortage, retailers such as CVS and Walgreens are limiting the number of containers customers can buy in a single visit.
Abbott’s voluntary recall was caused by four diseases reported in infants who consumed infant formula from the plant. All four babies were hospitalized for a rare type of bacterial infection and two died.
After six weeks of inspection, FDA investigators published a list of issues in March, including loose safety and hygiene standards, and a history of bacterial contamination in some parts of the plant. Under the agreement on Monday, Abbott will need to consult with external safety experts on a regular basis to resume and maintain production.
Chicago-based Abbott emphasizes that the product is not directly related to bacterial infections in children. Bacterial samples found at the factory did not match the strains collected from the two babies by federal investigators.
However, FDA officials pushed back the reason by calling reporters on Monday. For the first time, they publicly addressed the company’s claims. FDA staff said they were unable to collect bacterial strains from two of the four patients, limiting the chances of finding a match.
“From the beginning, there were only two sequences, limiting our ability to causally determine if a product was linked to these four cases,” said FDA Food Director Susan Mayne.
According to former FDA officials, it will take time to fix the violations found at Abbott’s factory. Companies need to thoroughly clean facilities and equipment, retrain staff, and repeatedly test and document pollution-free.
As part of the FDA’s new import policy, regulators said companies need to provide factory inspection documents.
According to pediatricians, milk powder produced in Canada and Europe is similar to that in the United States, but traditionally 98% of the supply of infant formula in the United States is produced domestically. Companies looking to enter the United States face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.
San Diego’s father, Stephen Hyde, had been prescribed Abbott, but faced the dire task of finding a prescription for his medically fragile daughter who had to switch to recalling other brands and subsequent shortages. I faced it.
Zoie Hyde was born 19 months ago in a rare life-threatening condition where he had no kidneys and needed dialysis and a feeding tube until he was heavy enough for a kidney transplant.
Hyde said he used foreign organic brands until cost and customs hurdles made it difficult. Davis said friends and strangers from outside the state sent him other brands, but each time she switched, she needed more blood tests and monitoring.
Despite her challenge, Zoe walks, talks, and “does pretty good” at other developmental milestones, Davis said.
“She is the shining light of my life,” he said.
AP Medical Writer Lindsey Tanner contributed to this story from Three Oaks, Michigan.